The Effect of Crystalloids and Colloids on Visceral Blood Flow

NCT01087853 | Completed Phase 1

• 2 other identifiers: 090632009-014774-18
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Patients often require fluid replacement during and after an operation. This is usually given through veins in the arm using an intravenous cannula and doctors have traditionally used fluid containing sodium chloride (saline). However accumulating evidence suggests that large infusions of saline are associated with adverse physiological effects including acidification of the blood and a rise in potassium and chloride levels. Studies in animals have shown that high levels of chloride in the blood and excess saline can cause blood vessels in the kidney to constrict leading possibly to a decrease in kidney function. Improvement in acid-base balance and kidney function may be observed with balanced solutions containing constituents that are more closely matched to the body's own fluid composition. However, little is known about the physiological effects of these solutions as they have only recently been developed. Magnetic resonance imaging (MRI) is a radiological modality which can now assess blood flow and supply of the kidney noninvasively without the need for the injection of radiological dyes known as contrast agents. This is now of major importance due to the possible adverse effects of MRI contrast agents leading to Nephrogenic Systemic Fibrosis (NSF), a progressive disease which has been observed in some kidney patients after receiving 'gadolinium based' contrast agents. This has therefore led to increased interest and demand for noncontrast based imaging methods. In this study we aim to compare the effects of balanced versus unbalanced fluid infusions in healthy human volunteers: We will aim to measure:

1. 1.Blood biochemical composition and acidity
2. 2.Kidney function and supply as measured by dynamic MRI

Conditions

Fluid Overload; Water Electrolyte Imbalance; Acid Base Imbalance

Keywords

Fluid Therapy; Water Electrolyte Imbalance; Acid Base Imbalance; Renal Circulation; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• The primary end point of each phase of this study will be a 6 mmol difference in serum chloride concentration after infusion of the balanced and unbalanced crystalloids and colloids.

  Phase A: Times 0, 60, 90, 120, 180 and 240 min and Phase B: Times 0, 30, 60, 120, 180 and 240 min

Secondary Outcomes (1)

• Changes in blood volume, renal and superior mesenteric arterial blood flow and vessel diameter.

  Phase A: Times 0, 60, 90, 120, 180 and 240 min and Phase B: Times 0, 30, 60, 120, 180 and 240 min

Study Arms (4)

Phase A1: Plasmalyte

ACTIVE COMPARATOR

Plasmalyte

Drug: Crystalloid

Phase A2: 0.9% Saline

ACTIVE COMPARATOR

0.9% Saline

Drug: Crystalloid

Phase B1: PlasmaVolume

ACTIVE COMPARATOR

PlasmaVolume

Drug: Colloid

Phase B2: Voluven

ACTIVE COMPARATOR

Voluven

Drug: Colloid

Interventions

Crystalloid DRUG

2 litres intravenous infusion in 60 minutes

Phase A1: Plasmalyte; Phase A2: 0.9% Saline

Colloid DRUG

1 litre intravenous infusion over 30 minutes

Phase B1: PlasmaVolume; Phase B2: Voluven

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• Male
• Aged between 18 and 40 years
• Weight between 65 and 80 kilograms
• Able to give informed consent

You may not qualify if:

• Chronic medical conditions
• Use of any regular medications
• History of substance abuse
• Known hypersensitivity to study infusion fluids
• Contraindications to MRI scanning

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Brain and Body MRI Centre, University of Nottingham

Nottingham, Nottinghamshire, NG7 2RD, United Kingdom

Location

Related Publications (1)

• Chowdhury AH, Cox EF, Francis ST, Lobo DN. A randomized, controlled, double-blind crossover study on the effects of 2-L infusions of 0.9% saline and plasma-lyte(R) 148 on renal blood flow velocity and renal cortical tissue perfusion in healthy volunteers. Ann Surg. 2012 Jul;256(1):18-24. doi: 10.1097/SLA.0b013e318256be72.

  PMID: 22580944 DERIVED

MeSH Terms

Conditions

Edema; Water-Electrolyte Imbalance; Acid-Base Imbalance

Interventions

Crystalloid Solutions; Colloids

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations; Complex Mixtures; Dosage Forms

Study Officials

• Dileep Lobo, MBBS MD FRCS

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 16, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 1, 2011

Record last verified: 2011-05

Locations

GB (1)